CEFTIN (nda050605)- (EQ 125MG BASE,EQ 250MG BASE,EQ 500MG BASE)

Generic Name	CEFUROXIME AXETIL	Innovator	GLAXOSMITHKLINE
Dosage	EQ 125MG BASE,EQ 250MG BASE,EQ 500MG BASE
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	CEFTIN is a cephalosporin antibacterial drug indicated for the treatment of the following infections due to susceptible bacteria:  Pharyngitis/tonsillitis (adults and pediatric patients)  Acute bacterial otitis media (pediatric patients)  Acute bacterial maxillary sinusitis (adults and pediatric patients)  Acute bacterial exacerbations of chronic bronchitis (adults and pediatric patients 13 years and older)  Uncomplicated skin and skin-structure infections (adults and pediatric patients 13 years and older)  Uncomplicated urinary tract infections (adults and pediatric patients 13 years and older)  Uncomplicated gonorrhea (adults and pediatric patients 13 years and older)  Early Lyme disease (adults and pediatric patients 13 years and older)  Impetigo (pediatric patients)

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
6	0	3

Other Developers

Total Other Developers	None

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 125MG BASE	**	**	-	-	-
EQ 250MG BASE	**	**	-	-	3
EQ 500MG BASE	**	**	-	-	3

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	2

Manufacturing Details of CEFTIN